thank you for joining ismpp u today! … · •speaker: laure haak, phd, executive director, orcid...
TRANSCRIPT
THANK YOU FOR JOINING ISMPP U TODAY!
The program will begin promptly at 11:00 am eastern
ISMPP WOULD LIKE TO THANK…..
…the following Corporate Platinum Sponsors for their ongoing support of the society
DATABASE AND RECORD RETENTION TO
ASSIST PUBLICATION PLANNERS
Laura L McCormick, PhD
Senior Vice President
ProEd Communications, Inc │ An Omnicom Company
June 27, 2012
ISMPP ANNOUNCEMENTS
• Mark your calendars! The 2013 European Meeting of ISMPP is
on 22–23 January 2013, ETC Venues, 200 Aldersgate, St Paul's,
London, UK
• Call for Abstracts is now open for the 2013 European Meeting.
Submission deadline is October 12th at 5:00pm EST.
• This program qualifies for 1 credit towards recertification
• Applications are now being accepted for the September CMPP
exam. Deadline for submission is August 15th. Visit the ISMPP
website for more information.
• Speaker: Laura McCormick (PhD) is Senior Vice President and Associate
Practice Leader for Scientific Communications at ProEd Communications
• Moderator: Manon Boisclair (MSc, RN, CMPP) is Director of Global
Scientific Communications—Myeloma Franchise at Celgene Corporation.
She is also an ISMPP University Committee member
Introduction
• Dr. McCormick oversees publications practice processes and policy for
ProEd and other HCG network companies. Her therapeutic areas of
expertise include allergy/immune-mediated diseases and oncology.
• Since joining ProEd in 2000, she has overseen content development and
process implementation for over 25 publication plans for a number of
pharma partners involving more than 300 manuscripts, countless congress
presentations and stand-alone meetings.
Speaker’s Short Bio
Disclosures
• Information presented reflects my personal knowledge and
opinion and does not represent those of my current or past
employers or those of the ISMPP
• Content presented includes guidance with legal implications
– I am not a lawyer and cannot guarantee the accuracy of legal
information
Today’s Objectives
• Understand the scope of document retention for publication
planning
– What to keep (type of documents)
– What not to keep
• Recognize the duration documents should be retained
• Understand best practices for document retention related to
Publications
• Understand changes in practices based on Corporate Integrity
Agreements (CIA) with the United States Office of the Inspector
General (OIG)
• Rationale for records retention
– Legal requirements
– Compliance documentation (OIG, ICMJE)
– Good management practice
• Types of records to retain for Publication planning and execution
– GPP2 and ICMJE compliance documentation
• Author letter
• Document reviews
– Draft copies
– Important correspondence
– Critical notes
Presentation Outline (1)
• Methods for record retention
– Proprietary databases
– Spreadsheets and other databases
• Duration of records for retention
– Legal requirements
– Practical aspects
Presentation Outline (2)
Background
• Corporate records hot topic: Sarbanes Oxley Act (SOX)
– Virtually every type of business document must be retained for a period
of time including e-mails, memos, work products, etc
• HIPAA regulates the manner in which personal information can
be stored
• Corporate Integrity Agreements (CIA) mandate records
• Purpose: Evidence that a business has complied with statutory
requirements under particular statutes
• Evidence is a record that clearly identifies relevant details
HIPAA = Health Insurance Portability and Accountability Act
Document Retention for Scientific Communications: Frame of Reference
• What is our frame of reference for today?
– Healthcare industry-sponsored publications
• Manuscripts: Primary/secondary/review/supplements
• Congress presentations: Abstracts/Posters/Orals
• Book chapters
• Other published materials subject to peer review and/or
ICMJE criteria for authorship
Legal Aspects of Document Retention
• How long should documents be retained?
– Most frequent guidance is duration of contract plus 7 years*
– My organization requires retention for lifetime of the active contract +
10 years; many pharmaceutical companies require contract + 10
– State laws govern retention of medical records, continuing medical
education, and other records
– Records management: Timeframe for retention of types of documents
varies by document types
• Refer to state and company regulations
• Follow your company’s and client’s policy for record retention and disposal *Rule of thumb: retain documents for active contract timeframe + 7 years or according to your institution’s or your client’s standards
(whichever is longest).
Legal Aspects of Document Retention
• Personal information cannot be maintained in widely accessible databases
or servers (locked or password protected files) according to federal privacy
laws and HIPAA
– Social security numbers
– Bank routing numbers
– Medical records
• Retained documents are “discoverable”
*Rule of thumb: retain documents for active contract timeframe + 7 years or according to your institution’s or your client’s standards
(whichever is longest).
Is this relevant to
Publications Management?
Consequences of Improper Document
Retention • Poorly organized, improper, or excessive document retention can result in
– False perceptions of compliance
– Loss of revenue (related to work hours)
– Violation of CIA issued by OIG
– Personal/corporate liability
• Retention of personal information (social sec # or bank routing #) or
medical information within compliance programs (ie, names on a scan)
violates US federal laws and HIPAA
• Intentional destruction of business records can constitute a criminal act
CIA = corporate integrity agreement; OIG = Office of the Inspector General
Scientific Communications Records: Types of Documents (1) • Physician/Author agreementsa, investigator/research contract,
study charter
• Manuscript/abstract/poster/slides drafts (content outline, each
draft)
– Retain each version circulated for reviewa
• Guidance on content (author, sponsor, any other)a
• Disclosures
– Financial
– Conflict of interest
aMaintain within compliance database if applicable
Scientific Communications Records: Types of Documents (2) • Correspondencea
– Author
– Expert consultant or statistician
– Sponsor
– Journal
• Copyright documents
– Signed agreements
– Permission to adapt or reproduce
• Letters of acceptance/rejectionb, solicitation letter to journal
a Include level of detail necessary to accurately reflect content guidance received from all involved parties within compliance database.
b Maintain within compliance database if applicable
Scientific Communications Records: Types of Documents (3)
• Contracts (stats analysis, clinical interpretation) or any evidence
of payment
• Other compliance documentationa
– E-mails to clarify miscommunications
– Documentation to correct compliance violations
• Any other document related to legal or compliance mattersa
• Notes regarding actions taken, advice given, etc.
• Documentation of audits performed (internal/external)
aMaintain within compliance database if applicable
Scientific Communications Records: Types of Documents (4)
• Source Data to document data accuracy
– All patient data, scans, images, etc., must be “de-identified”
– Privacy laws vary globally
• Extra vigilance is necessary when physicians e-mail images
aMaintain within compliance database if applicable
How Much is Enough?
• Should you retain
– Every e-mail?
– Every manuscript draft?
• Should you upload all project documents, notes, queries into
compliance management programs?
How Much is Enough?
• Remember CIAs (typically) stipulate routine audits!
– Routine compliance officer audits
• Author and other reviewer comments
• Author contract/letter (correct level of involvement)
• Identification of missing information (notes, dates, contracts, etc.)
• Interim and final submitted document versions
– Random OIG audits
• Including details that are irrelevant to documentation of accurate
business records and/or compliance could complicate the audit
How Much is Enough? General Guidelines
• Content documents (ie, manuscripts, abstracts)
– Each relevant milestone (CO, 1st draft and subsequent drafts circulated
for review, submitted draft)
– All comments regardless of source
– Verbal content direction (minutes/notes from author TC)
How Much is Enough? General Guidelines • Correspondence
– Notable communications (ie, clarifying authorship or author order,
comments in e-mails, controversial topics, key decisions)
– Communications clarifying an e-mail that could be misinterpreted as a
compliance violation
– Most organizations auto-delete e-mail
• Archive e-mails that constitute business records within project server or
compliance database (ie, those that relate to compliance, direction, etc.)
Some Special Notes About E-mails • Should the communication be conducted in writing?
– In sticky situations it is wise to pick up the phone: correspondence can
be misleading if not all facts are correct
• Consider who should be copied on sensitive communications
• Should sensitive e-mails receive a reply or be forwarded to
others?
– For sensitive topics consider the consequences of an e-mail being read
out of context? Will it still make sense?
– Always clarify communications that could create a misperception
Methods for Document Retention
• Proprietary databases
– Datavision
– Sylogent
– Please Review
– Others
• Excel spreadsheets
• Well-organized server folder structure
Compliance
Document Retention = Compliance
Compliance
• Document retention can never replace Good Publication
Practice (GPP2)
• BUT proper documentation can
– Capture compliance violations
– Demonstrate compliance with company policies, CIA, and
GPP2/ICMJE
Developing SOPs For Publication Document Retention
• Know your company’s policy
• Know your client’s policies
• Conduct annual training
– Document retention
– Publication database management
– Communication etiquette
Document Retention Best Practices:
Conclusions
• Comprehensive knowledge of document retention and
destruction policies of your employer and clients is important for
publication planning professionals
• Retention of records that accurately reflect author involvement,
publication draft milestones, content direction, contracting, and
adherence with CIA and company policies is critical
Document Retention Best Practices: Conclusions • Organization of records is a must!
– Saves time/money
– Reduces compliance officer effort
• For specific guidance, refer to company/client policies regarding
– Type of records to retain
• Specific caveats regarding correspondence and notes/minutes
– Duration of record retention
– Records destruction
QUESTIONS......
To ask a question, please type your query into the
‘Q&A’ chat box at the bottom left of your screen.
Every attempt will be made to answer all questions.
THANK YOU
Laura L McCormick, PhD
Senior Vice President
ProEd Communications, Inc │ An Omnicom Company
NEXT ISMPP U
• Date: Wednesday, July 25th
• Topic: Introducing ORCID (Open Researcher &
Contributor ID): How to Use this Novel and Independent
Author/Contributor Disambiguation System to Simplify
Manuscript Submission and Processing
• Speaker: Laure Haak, PhD, Executive Director, ORCID
• Moderator: Tim Bacon, CMPP; CEO, Medicine in Practice, Inc.
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